The Company & Role
Our client a large biopharmaceutical company specialising in the development and engineering of cell-based therapies is looking for a Medical Director based in Belgium. The company’s ambition is to develop a unique immunotherapeutic approach to offer new treatment options to cancer patients. The team is currently focusing on the development of a new T-cell therapy that has the potential to target and destroy 80% of cancer types.
Your role will be to provide medical guidance and leadership throughout the development and conduct of clinical trials in the immune-oncology area. You will be responsible designing and/or managing the implementation of the clinical strategy within Clinical Development globally.
1. Lead Clinical Development activities for a series of studies
- Develop clinical trial strategies, design study protocols, monitor, document, and interpret clinical study data;
- Implement safety strategy across studies, including regular review of safety data and response to safety issues including communications with investigators and regulatory agencies;
- Perform medical assessment for expedited reporting, annual reports, Periodic Reports, and Periodic Safety Update Reports;
- Lead medical sections of regulatory documents in EU and US; assist team with preparations for regulatory agency meetings and reports, including patient and safety narratives;
- Provide medical support to clinical operations team.
2. Serves as scientific reference for the Company (internally/externally)
- Represent company in meetings with health authorities, the scientific community, and international agencies as needed;
- Publish clinical data in peer review journals and present in external scientific meetings/congresses;
- Manage Key Opinion Leaders, Clinical Steering Committee and Advisory Boards.
Qualifications & Experience
- Medical degree and experience as a physician or academic;
- Specialty training in Oncology is highly desirable;
- Experience working within Immuno-Oncology is highly desirable;
- At least 3 to 5 years clinical experience in biopharmaceutical, biotechnology industry;
- Sound scientific background required to critically evaluate all scientific aspects of oncology;
- Knowledge of clinical stage drug development efforts;
- Experience interpreting clinical data and managing safety strategy;
- Experience preparing and reviewing documents for clinical development to ensure high-quality document submissions health authorities and regulators (knowledge of biomedical research regulation);
- Fluency in English (written and spoken).